Biosimilars

CVS Steps Into Biosimilar Space With New Subsidiary Cordavis

CVS Health is getting into the biosimilars business, the company said in late August, and will officially enter the market on Jan. 1 in partnership with a Humira biosimilar. CVS stressed the importance of driving use of biosimilars and ensuring their supply, which sources say is a positive development. But one industry source questions whether the new company raises potential conflict-of-interest issues.

On Aug. 23, CVS revealed that it had launched the wholly owned subsidiary Cordavis to commercialize and/or co-produce biosimilars in collaboration with drug manufacturers. “Through Cordavis, CVS Health intends to develop a portfolio of products that it expects will facilitate broader access to biosimilars in the U.S. — creating more competition that drives down prices — while encouraging investment in future products,” said the company in a press release.

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Now That Humira Biosimilars Have Launched, What Are Lessons Learned for Stelara Biosimilars?

Following the launch of almost 10 biosimilars of AbbVie Inc.’s Humira (adalimumab) this year, 2025 will be another big year for the U.S. biosimilar market, when no less than three versions of Stelara (ustekinumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson are set to become available. Having the experience of assessing multiple competitors with varying attributes could help payers as they prepare for the launches, say industry experts.

Stelara is a human interleukin-12 (IL-12) and -23 (IL-23) antagonist indicated for the treatment of adults with moderately to severely active Crohn’s disease, adults with moderately to severely active ulcerative colitis, people at least 6 years old with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy and people at least 6 years old with active psoriatic arthritis.

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CVS Launches New Biosimilar White Label, But Can it Bring Down Costs?

CVS Health Corp. plans to launch its own white-label line of biosimilars, the retail and health care giant said on Aug. 23, in a play to lower specialty pharma costs. Experts say that it could be years before anyone is able to tell whether the venture has brought down costs — especially since the biosimilar market itself is still in its early stages of development.

The new CVS brand, Cordavis, will be “a wholly owned subsidiary that will work directly with manufacturers to commercialize and/or co-produce biosimilar products,” a press release said. The division “will help ensure consistent long-term supply of affordable biosimilars,” and, in doing so, leverage “one of the biggest opportunities for reducing drug costs for employers and consumers.”

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News Briefs: Sen. Mike Lee Reintroduced Biosimilar Red Tape Elimination Act

Sen. Mike Lee (R-Utah) reintroduced the Biosimilar Red Tape Elimination Act (S. 2305), his office said on July 13. The legislation is focused on increasing competition among biologics and lowering consumer costs for them. He first introduced the bill, which would do away with the FDA requirement for switching studies for biosimilars seeking the interchangeability designation, on Nov. 17, 2022. The legislation has been referred to the Senate Committee on Health, Education, Labor, and Pensions.

Clearway Health is working with The Brooklyn Hospital Center to help improve access to specialty pharmacy drugs for underserved patients, Clearway Health said on Aug. 2. The company, which partners with hospitals and health systems to build or improve their own specialty pharmacy programs, said it will help the hospital by broadening its services, decreasing patients’ financial responsibilities, improving patient adherence and boosting clinical outcomes.

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New FDA Approvals: FDA Expands Label of Novartis’ Leqvio

July 7: The FDA broadened the label of Novartis Pharmaceuticals Corp.’s Leqvio (inclisiran) to include its use as an adjunct to diet and statin therapy to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. The agency initially approved the small interfering RNA (siRNA) therapy on Dec. 22, 2021. Dosing is 284 mg via a subcutaneous injection by a health care professional, then another dose at three months and then every six months. The drug’s list price is $3,290.63 per dose.

July 11: The FDA expanded the label of Organon’s Hadlima (adalimumab-bwwd) to include the treatment of adults with non-infectious intermediate and posterior uveitis and panuveitis. The agency first approved the biosimilar of AbbVie Inc.’s Humira (adalimumab) on July 23, 2019. Dosing starts with 80 mg via subcutaneous injection, followed by 40 mg every other week starting one week after the initial dose. The agent is available in both low-concentration and high-concentration versions of its reference drug. The product recently launched with a wholesale acquisition cost of $1,038 for a carton of two syringes or autoinjectors.

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PSG Report Shows Double-Digit Specialty Drug Trend, but Opportunities for Savings Exist

Specialty drug trend continues to be in consistent double digits, with increases due to both spend and trend. That’s one of the findings of the 2023 Artemetrx Specialty Spend & Trend Report from the Pharmaceutical Strategies Group (PSG), an EPIC company. And with the specialty drug pipeline continuing to pump out more and more expensive agents, opportunities for savings exist through the use of biosimilars and generic specialty drugs, among other strategies.

Published July 25, the report is sponsored by Walmart Specialty Pharmacy and includes data from 2022. Findings are based on an analysis of 347 million medical claims and 133 million pharmacy claims from PSG’s Artemetrx book of business. Artemetrx is a proprietary SaaS platform developed by PSG. This is the seventh annual version of the report, which started under the Pharmacy Benefit Management Institute (PBMI) moniker. In April 202, MJH Life Sciences acquired PBMI’s trademarks, conference, website, education and membership assets, while the current and future research and analytics projects remained with PSG.

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Hospital Settings Drive Up Spending on Biologics, Biosimilars

A new study from the Employee Benefit Research Institute highlights the high — and growing — markups that hospital outpatient departments assign to biologic drugs, while also examining the variation in how HOPDs and physician offices (POs) treat innovator biologics compared to their biosimilars.

The study analyzed medical and pharmacy claims data from Merative MarketScan Commercial Database — which covers nearly 25 million people with private health insurance — from 2013 to 2020, and it focused on seven innovator biologics and their biosimilars that had been launched as of 2020.

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Markup Malaise: Research Highlights Site-of-Care Cost Differences for Biologics

The large markups that hospital outpatient departments (HOPDs) place on biologic medicines are both causing plan sponsors’ costs to soar and muting the potential savings that could come from biosimilars, according to a new report from the Employee Benefit Research Institute (EBRI). One of the report’s coauthors says that health care provider consolidation is largely the culprit — and it’s an issue that plan sponsors may struggle to combat.

While physician practices also mark up the prices of provider-administered drugs, HOPDs generally raise them even more, explains Paul Fronstin, Ph.D., director of health benefits research at EBRI. “And that’s because they’ve got purchasing power, and the purchasing power is increasing as they acquire more and more physician practices,” he adds.

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Hospital Settings Drive Up Spending on Biologics, Biosimilars

A new study from the Employee Benefit Research Institute highlights the high — and growing — markups that hospital outpatient departments assign to biologic drugs, while also examining the variation in how HOPDs and physician offices (POs) treat innovator biologics compared to their biosimilars.

The study analyzed medical and pharmacy claims data from Merative MarketScan Commercial Database — which covers nearly 25 million people with private health insurance — from 2013 to 2020, and it focused on seven innovator biologics and their biosimilars that had been launched as of 2020.

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Significant Specialty Drug Trend Increase Is Expected to Continue

Over the next few years, numerous biosimilars are expected to hit the U.S. market, leading to more competition and potentially lower costs for some expensive medications. However, that will not be enough to offset the entrance of new high-cost drugs and expanded indications for specialty medicines, according to the latest Pharmaceutical Strategies Group (PSG) “Spend and Trend” report.

The analysis, published on July 25, found that the per member per year (PMPY) cost for specialty drugs was $1,169 in 2022, a 14.1% increase from the previous year. After factoring in rebates, the PMPY increased by 12.5%, from $822 in 2021 to $925 in 2022.

PSG projects that the pre-rebate and post-rebate PMPY in 2025 will be $1,712 and $1,370, representing a 46.5% and 48.5% increase from last year, respectively.

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